Principal Investigator: Jeffry Skiba
Performing Organization: NuShores Biosciences LLC
NuShores Biosciences LLC is conducting a prospective, first-in-human clinical trial to evaluate the safety and performance of its NuCress™ Bone Void Filler (BVF) for use in localized alveolar ridge augmentation following tooth extraction. NuCress™ BVF is a porous, degradable, and osteoconductive investigational device. Engineered to mimic the native healing environment of bone, the material allows cellular infiltration, vascular ingrowth, and new bone formation through its hydrophilic and interconnected porous structure. Over time, NuCress™ BVF is gradually degraded and replaced by the patient’s own bone. The device is intended for the treatment of surgically created or trauma-induced bony voids in craniofacial regions and aims to reduce surgical complexity and healing delays compared to conventional grafting approaches.
This controlled, single site, clinical investigation will enroll 85 patients requiring extractions in the maxilla or mandible. Patients will be randomized into four study groups: The first group will only receive the NuCress™ BVF treatment, the second one will receive a market available comparator device, the third one will be a split-mouth design treatment comparing NuCress™ BVF to the market comparator device, and the fourth one will be an empty defect (no grafting material).
All patients will undergo standardized surgical procedures, including atraumatic extractions, material placement (where applicable), and closure. Patients will return for clinical follow-up and evaluation post-procedure at clinically relevant time intervals. These assessments will include imaging, clinical examinations, and the retrieval of a bone core sample at the time of dental implant placement, which will be used to analyze bone quality and volume through micro-computed tomography and histologic examination. Implant stability will be assessed using standard clinical assessment approaches.
The main objectives of the study are to demonstrate that NuCress™ BVF allows adequate bone formation, as measured by radiographic and histological evidence, to restore alveolar ridge dimensions following tooth extraction, and to evaluate implant stability within the formed bone at different time intervals. Additional objectives include the evaluation of device handling, its hydrophilicity and ability to help improve surgical procedures, as reported by the surgical team. This study will aim to prove that NuCress™ BVF can safely and effectively support early bone formation in post-extraction sockets, with the potential to reduce treatment time and procedural complexity. Results from this trial may help expand future treatment options for both civilian and military patients requiring dental reconstruction.